Cleared Traditional

K192310 - Flap Fixator, Burr Hole Cover

K192310 is an FDA 510(k) clearance for Flap Fixator, manufactured by Ossaware Biotech Co., Ltd.. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K192310 · Ossaware Biotech Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
282d
Days
Class 2
Risk

K192310 is an FDA 510(k) clearance for the Flap Fixator, Burr Hole Cover. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Ossaware Biotech Co., Ltd. (Shenkang Hsiang, TW). The FDA issued a Cleared decision on June 3, 2020 after a review of 282 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ossaware Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K192310

510(k) Number K192310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2019
Decision Date June 03, 2020
Days to Decision 282 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 148d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXR Cover, Burr Hole

All 25
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K192310.
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
K253447 · Orthocon, Inc. · Mar 2026
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
K240137 · Neos Surgery S.L · Feb 2024
Absorbable Cranial Flap Fixation System
K221606 · Chendu Medart Medical Scientific Co., Ltd. · Nov 2023
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
K192162 · Neurovention, LLC · Mar 2020
OSSDSIGN Cranioplug
K181539 · Ossdsign AB · Oct 2018
GuardianTM Burr Hole Cover System
K181382 · St Jude Medical · Jul 2018